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Obstructive Sleep ApneaMaSTNCT05539716

Metabolism and Sleep Apnea Treatment

A study testing PAP Therapy and Lifestyle Counseling Intervention in people with Obstructive Sleep Apnea and Fat Disorder, run by University of Miami at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this research study is to see if obstructive sleep apnea (OSA) is associated with abnormalities in fat metabolism. Through this research study, the Investigator will evaluate how fat is metabolized in people with and without sleep apnea, what substances the fat tissue releases, and how these substances… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Obstructive Sleep Apnea, Fat Disorder
What is being tested?
PAP Therapy and Lifestyle Counseling Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
20 May 2022to 1 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age between 18-70 years
  • Ability to provide consent
  • Age between 18-70 years
  • Ability to provide consent
  • Moderate-to-severe OSA (AHI ≥ 15/h);
  • Demonstration of Positive Airway Pressure (PAP) use of > 4 h/night on 70% of the nights during 1-week run-in period
  • Successful completion of all of the procedures for Aim 1.

Who cannot join

  • Body Mass Index (BMI) > 40 kg/m2
  • Prevalent myocardial infarction, coronary revascularization, heart failure, and stroke
  • Type 1 or Type 2 diabetes mellitus
  • Current or prior use of PAP or oral appliance therapy for OSA
  • Use of oral corticosteroids
  • Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)
Show all 23Show fewer
  • Other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleep duration < 6h)
  • Use of supplemental oxygen during wakefulness or sleep
  • Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respiration based on the home sleep test
  • Resting awake Oxygen Saturation (SpO2) < 90%
  • Aim 2 Group:
  • BMI: ≥ 40 kg/m2
  • Type 1 or Type 2 diabetes mellitus
  • Current use of PAP or oral appliance therapy for OSA
  • Commercial driver or report of motor vehicle accident or near-miss due to sleepiness within the 2 previous years
  • Epworth sleepiness score of 18 or more
  • Use of oral corticosteroids
  • Participation in another clinical trial
  • Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)
  • Other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleep duration < 6h)
  • Use of supplemental oxygen during wakefulness or sleep
  • Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respiration based on the home sleep test
  • Resting awake SpO2 < 90%

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Naresh Punjabi, MD contact

305-243-3963

npunjabi@miami.edu

United States1 site, 1 recruiting

  • University of Miami

    Miami, Florida, 33143

    Naresh Punjabi, MD, 305-243-3963, npunjabi@miami.edu

    Naresh Punjabi, MD

    Recruiting

Other trials in United States

About this study

The purpose of this research study is to see if obstructive sleep apnea (OSA) is associated with abnormalities in fat metabolism. Through this research study, the Investigator will evaluate how fat is metabolized in people with and without sleep apnea, what substances the fat tissue releases, and how these substances might change the way the body uses energy and sugar.

Being tested
PAP Therapy, Lifestyle Counseling Intervention
Medical subject headings
Sleep Apnea, Obstructive, Lipid Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PAP TherapyDevice

    Auto-PAP device (ResMed AirsenseTM Autoset) with a heated humidifier will be provided along with an appropriate mask and connecting hose for nightly use

  • Lifestyle Counseling InterventionBehavioural

    Lifestyle intervention will include counseling on (a) education on nutrition and exercise; and (b) behavioral support for identifying lifestyle change strategies and problem-solving barriers to improve the regularity and duration of sleep. This will be conducted using brochures on weight loss and sleep hygiene

Study groups in NCT05539716
Study groupRoleWhat they receive
No Intervention (Aim 1) GroupNo interventionParticipants in this group will not receive an intervention and will only undergo several testing procedures conducted within 3 to 4 weeks to assess OSA severity.
PAP Therapy and Lifestyle Intervention (Aim 2) GroupExperimentalParticipants in the Aim 1 Group found to have moderate to severe OSA (defined as having a Apnea-Hypopnea Index (AHI) of 15.0 events/hour or more) randomized to this arm will receive the PAP therapy and Lifestyle Intervention for 12 weeks.
Receives: Device: PAP Therapy; Behavioral: Lifestyle Counseling Intervention
Lifestyle Intervention Only (Aim 2) GroupExperimentalParticipants in the Aim 1 Group found to have moderate to severe OSA (defined as having a Apnea-Hypopnea Index (AHI) of 15.0 events/hour or more) randomized to this arm will receive only the Lifestyle Intervention for 12 weeks.
Receives: Behavioral: Lifestyle Counseling Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Whole body lipolysis rate

    Measured using the Intravenous Glucose Tolerance Test (IVGTT) in micromoles/L/min assessed at baseline and again at 3 months

    Measured: Up to 3 months

Secondary outcomes (8)

  1. Free Fatty Acids (FFA) Oxidation Rate

    Measured using the IVGTT in micromoles/L/min assessed at baseline and again at 3 months

    Measured: Up to 3 months

  2. Adipocyte insulin resistance

    Measured using the IVGTT in micromoles-microunits/L-ml assessed at baseline and again at 3 months

    Measured: Up to 3 months

  3. Lipolysis suppression slope

    Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months

    Measured: Up to 3 months

  4. Free fatty acid rebound slope

    Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months

    Measured: Up to 3 months

  5. Free fatty acid insulin sensitivity parameter

    Measured using the IVGTT in (picomoles/L x min)^-1 assessed at baseline and again at 3 months

    Measured: Up to 3 months

  6. Insulin sensitivity

    Measured using the IVGTT in (milliunits/L x min)^-1 assessed at baseline and again at 3 months

    Measured: Up to 3 months

  7. Acute insulin response to glucose

    Measured using the IVGTT in (milliunits/L) x minute assessed at baseline and again at 3 months

    Measured: Up to 3 months

  8. Glucose effectiveness

    Measured using the IVGTT in per minute assessed at baseline and again at 3 months

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2022
  2. Study start20 May 2022
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05539716
Sponsor's protocol ID
20210670
Other IDs
5R01HL146709-04
Acronym
MaST
Status last verified
Mar 2026
First submitted
16 May 2022
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PAP Therapy and Lifestyle Counseling Intervention in people with Obstructive Sleep Apnea and Fat Disorder, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Naresh Punjabi, MD (305-243-3963, npunjabi@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Whole body lipolysis rate (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05539716.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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